• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST MEGA SUTURECUT ND

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC ENDOWRIST MEGA SUTURECUT ND Back to Search Results
Model Number 471309-15
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm mega suture cut needle driver instrument had broken wires. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) has performed follow-up to attempt to obtain additional information related to the event. However, as of the date of this report, no further details have been provided.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the 8mm mega suture cut needle driver instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/ confirmed the customer reported complaint. Failure analysis found the primary failure of a broken pitch cable to be related to the customer reported complaint. The mega suture cut needle driver instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was still installed in the clevis. The pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material. The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics. Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure. The root cause of this failure is attributed to a component failure and related to device design. A review of the instrument log for the mega suture cut needle driver (471309-15/k132106210127) associated with this event has been performed. Per logs, the mega suture cut needle driver was last used in a procedure on (b)(6) 2021 on system (b)(4). The alleged instrument had 9 uses remaining after the last procedural use. A review of the site's complaint history found that there were no other complaints for this product. No image or video of the last procedure was provided for review. Based on the information provided at this time, this complaint is being reported based on the failure analysis findings. A mega suture cut needle driver instrument is designed with two pitch cables, each with a crimp at the distal end. If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall inside the patient. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceMEGA SUTURECUT ND
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13058537
MDR Text Key290153876
Report Number2955842-2021-11791
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874119815
UDI-Public(01)00886874119815(10)K13210621
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471309-15
Device Catalogue Number471309
Device Lot NumberK13210621 0127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
-
-